2024 in Review: FDA Approvals and Product Launches
Last year brought remarkable advances in eye care, with various products receiving FDA approval and/or becoming commercially available. From groundbreaking devices to novel therapies, these innovations reflect progress across all optometric subspecialties. This article provides a rundown of 2024’s highlights for treating conditions such as ocular surface disease, presbyopia, cataracts, glaucoma, and retinal diseases. (For developments to keep an eye on in 2025, see Products in the Pipeline.)
DRY EYE AND OCULAR SURFACE DISEASE
A Water-Free, Preservative-Free Drop
Launched in January 2024, cyclosporine ophthalmic solution 0.1% (Vevye, Novaliq and Harrow Health) is comprised of a semifluorinated alkane formulation.1 The ESSENCE-1 and ESSENCE-2 clinical trials demonstrated corneal staining reduction within 4 weeks, as well as sustained improvement over 56 weeks.2
A Biocompatible, Crosslinked Hyaluronic Acid Gel
Lacrifill Canalicular Gel (Nordic Pharma) launched in May and is designed to occlude the canalicular system, allowing the eye’s natural tears to remain on the ocular surface longer.3 Clinical trial results showed improved Schirmer scores, corneal staining, and Ocular Surface Disease Index scores in patients treated with Lacrifill, with benefits sustained over 6 months.4
A Daily Nutritional Supplement
Blink NutriTears (Bausch + Lomb) came to market in June 2024 and combines lutein, zeaxanthin, curcumin, and vitamin D to target tear production. Clinical studies showed improvement in tear production and symptom relief within 14 days.5
An Ophthalmic Formulation Borrowed From Dermatology
Launched in September, clobetasol ophthalmic suspension 0.05% (Eyenovia) is the first ophthalmic formulation of clobetasol, a corticosteroid traditionally used in dermatology. Adapted for ocular use, it is indicated for postoperative inflammation and pain management following ocular surgery.6 In clinical trials, 80% of patients experienced complete pain relief within 4 days.7
A Noninvasive, Thermal-Based Device
FDA-cleared in November, Tixel (Novoxel) uses proprietary Thermo-Mechanical Action technology to deliver localized heat and pressure to the upper and lower eyelids.8 It is designed to treat meibomian gland dysfunction through a series of three treatments spaced 2 weeks apart. A multi-site clinical study showed improvements in tear breakup time and meibomian gland secretions following treatment with Tixel.8
PRODUCTS IN THE PIPELINE
If you feel caught up on the news from last year, check out the following medications and technologies on the horizon:
A Novel TRPM8 Agonist
AR-15512 (Alcon) is designed to treat dry eye by stimulating cold-sensing receptors, thus boosting natural tear production and relieving symptoms.1 Results from the phase 3 COMET-2 and COMET-3 clinical trials demonstrated significant improvements in Schirmer scores as early as day 1, with benefits sustained through day 90.1
A Tri-Specific Antibody
EB-105 (Eluminex Biosciences) targets VEGF-A, VEGF-B, Ang-2, and IL-6R to treat various retinal diseases. Phase 1b clinical trials are underway to evaluate EB-105 as a treatment for diabetic macular edema.2
An Epi-On Corneal Crosslinking System
EpiSmart Crosslinking (Epion Therapeutics) is designed to strengthen corneal tissue without removing the epithelium. This approach aims to minimize recovery time and improve patient comfort. The Apricity phase 3 clinical trials are underway to evaluate its efficacy and safety in treating keratoconus.3
An Ectoparasiticide
Lotilaner ophthalmic solution 0.25% (Xdemvy, Tarsus Pharmaceuticals), approved for the treatment of Demodex blepharitis, is now being investigated for the treatment of meibomian gland dysfunction, with promising results from the phase 2a ERSA trial.4
A RASP Modulator
The FDA accepted a new drug application for reproxalap (Aldeyra Therapeutics) last year, with a Prescription Drug User Fee Act of April 2, 2025.5 Reproxalap is in development for the treatment of dry eye disease and allergic conjunctivitis and works by modulating reactive aldehyde species to reduce inflammation.
A Drop for Presbyopia
FDA-approved in 2023, pilocarpine hydrochloride ophthalmic solution 0.4% (Qlosi, Orasis Pharmaceuticals) offers a lower pilocarpine concentration for the treatment of presbyopia, resulting in fewer side effects. Orasis Pharmaceuticals reached a deal in October 2024 to support the commercial launch of the drop in the United States.6
1. Alcon announces positive topline results from phase 3 COMET trials of AR-15512, a novel topical drug candidate for dry eye [press release]. Alcon. January 9, 2024. Accessed January 5, 2025. www.alcon.com/media-release/alcon-announces-positive-topline-results-phase-3-comet-trials-ar-15512-novel-topical/
2. Eluminex Biosciences announces first patient dosed in the phase 1b LOTUS trial of the novel trispecific fusion antibody EB-105 in diabetic macular edema (DME) [press release]. Eluminex Biosciences. July 15, 2024. Accessed January 5, 2025. www.prnewswire.com/news-releases/eluminex-biosciences-announces-first-patient-dosed-in-the-phase-1b-lotus-trial-of-the-novel-trispecific-fusion-antibody-eb-105-in-diabetic-macular-edema-dme-302196410.html
3. Epion Therapeutics Initiates Phase 3 Clinical Trials for Minimally Invasive Keratoconus Treatment [press release]. Epion Therapeutics. Accessed January 5, 2025. www.epiontx.com/news/epion-therapeutics-initiates-phase-3-clinical-trials-for-minimally-invasive-keratoconus-treatment-9j4c6
4. Positive topline results from the Ersa phase 2a clinical trial evaluating TP-03 for the treatment of meibomian gland disease in patients with Demodex mites [press release]. Tarsus Pharmaceuticals. December 11, 2023. Accessed January 5, 2025. www.globenewswire.com/news-release/2023/12/11/2793790/0/en/Tarsus-Announces-Positive-Topline-Results-from-the-Ersa-Phase-2a-Clinical-Trial-Evaluating-TP-03-for-the-Treatment-of-Meibomian-Gland-Disease-in-Patients-with-Demodex-Mites.html
5. Aldeyra Therapeutics Announces FDA Acceptance for Review of Reproxalap New Drug Application for the Treatment of Dry Eye Disease, Expands AbbVie Option Agreement [press release]. November 18, 2024. Accessed January 10, 2025. ir.aldeyra.com/news-releases/news-release-details/aldeyra-therapeutics-announces-fda-acceptance-review-reproxalap
6. Delaney-Gesing A. Orasis secures financing to support US commercial launch of Qlosi. Eyes on Eyecare. October 8, 2024. Accessed January 17, 2025. glance.eyesoneyecare.com/stories/2024-10-08/orasis-secures-financing-to-support-us-commercial-launch-of-qlosi/
CATARACT AND REFRACTIVE SURGERY
A Wavefront-OptimizedLaser Platform
FDA-cleared in January 2024, Teneo Excimer Laser Platform (Bausch + Lomb) uses wavefront-optimized technology, minimizing higher-order aberrations and improving visual outcomes.9 Teneo is indicated for the treatment of myopia and myopic astigmatism.
A Software Upgrade
VisuMax 800 SMILE (Carl Zeiss Meditec) is a software that was FDA-cleared in January 2024 and optimizes the speed and precision of lenticule creation for small-incision lenticule extraction refractive procedures.10 A faster pulse repetition rate reduces surgical time and improves patient comfort and visual outcomes.
An Adjustable IOL
The Light Adjustable Lens+ (LAL+, RxSight), launched in April, allows postoperative adjustments and features an enhanced depth of focus compared with its predecessor, improving intermediate and distance vision for patients.11
Full Visual Range IOL
Launched in September, the Tecnis Odyssey IOL (Johnson & Johnson Vision) minimizes halos and glare, while enhancing contrast sensitivity.12
Wavefront-Optimized Optics
The Envista Envy Lens (Bausch + Lomb) employs wavefront-optimized optics to provide sharp vision at all distances, while reducing halos and glare.13 This lens was FDA-approved in October.
GLAUCOMA
An Intracameral Implant
Launched in the first quarter of 2024, the travoprost intracameral implant (iDose TR, Glaukos) is designed to deliver sustained travoprost therapy for up to 3 years.14 Phase 3 pivotal trials, GC-010 and GC-012, demonstrated significant IOP reductions and a favorable safety profile, with many patients remaining medication-free after 12 months following a single administration of iDose TR.15
An Important Generic Option
FDA-approved in May, travoprost ophthalmic solution USP 0.004% (Lupin Pharmaceuticals), the generic equivalent of Travatan Z (Sandoz), provides a cost-effective solution for reducing IOP in patients with glaucoma or ocular hypertension.16
A Pump That Adjusts Ocular Pressure
Designed to lower IOP through controlled negative pressure during sleep, the FYSX Ocular Pressure Adjusting Pump (Balance Ophthalmics) offers a noninvasive treatment for patients with glaucoma.17 The ARTEMIS clinical trial reported that 63.4% of treated eyes achieved an IOP reduction of 20% or more compared with 3.2% in control eyes.18 The APOLLO clinical trial demonstrated similar efficacy in patients with open-angle glaucoma, further validating the device’s effectiveness for reducing IOP with nightly use.19 The FYSX Ocular Pressure Adjusting Pump was FDA-cleared in June and is expected to launch in late 2025.
A Device for Direct Selective Laser Trabeculoplasty (DSLT)
Developed by Belkin Vision and FDA-cleared in December 2023, the Eagle device uses DSLT to deliver a non-contact, automated laser therapy for glaucoma without the need for a gonioscopy lens.20 In May 2024, Alcon acquired Belkin Vision and rebranded it as the Voyager DSLT with a limited US launch in 2024.21 In the GLAUrious Study, DSLT was shown to achieve IOP reductions comparable with that of traditional SLT.22
RETINA
Aflibercept Biosimilars
Five aflibercept 2 mg (Eylea, Regeneron) biosimilars were approved in 2024, providing more affordable options for treating retinal conditions (eg, neovascular age-related macular degeneration, diabetic retinopathy, diabetic macular edema, and macular edema following retinal vein occlusion):
- aflibercept-jbvf (Yesafili, Biocon Biologics); May 2023
- aflibercept-yszy (Opuviz, Samsung Bioepis and Biogen); May 2023
- aflibercept-mrbb (Ahzantive, Formycon and Klinge Biopharma); June 2824
- aflibercept-abzv (Enzeevu, Sandoz); August 1225
- aflibercept-ayyh (Pavblu, Amgen); August 2326
Photobiomodulation Device
The Valeda Light Delivery System (LumiThera) was FDA-cleared in May and uses photobiomodulation to stimulate mitochondrial function in retinal cells, addressing vision loss in dry age-related macular degeneration.27 Granted de novo classification, the LIGHTSITE III trial showed that treated patients gained more than 5 ETDRS letters at 24 months compared with baseline.27
INDUCED MYDRIASIS
Preservative-Free Pupil Dilation Reversal
Phentolamine Ophthalmic Solution 0.75% (Ryzyumvi, Ocuphire Pharma) was launched in April and is the first FDA-approved drop for reversing pharmacologically induced mydriasis.28 MIRA-2 and MIRA-3 trials confirmed rapid pupil recovery within 90 minutes with no reported significant adverse effects.28
LOOKING FORWARD TO ANOTHER GREAT YEAR
Last year was transformative for eye care, marked by novel FDA approvals and product launches that enhanced patient outcomes across all subspecialties. With these approvals and promising pipeline developments, the future of eye care continues to look bright, emphasizing improved outcomes for our patients.
1. Harrow announces availability of Vevye (cyclosporine ophthalmic solution 0.1%), the first and only cyclosporine-based product indicated for treating both signs and symptoms of dry eye disease [press release]. Harrow. January 11, 2024. Accessed January 5, 2025. investors.harrow.com/news-releases/news-release-details/harrow-announces-availability-vevyer-cyclosporine-ophthalmic
2. Akpek EK, Wirta DL, Downing JE, et al. Efficacy and safety of a water-free topical cyclosporine, 0.1%, solution for the treatment of moderate to severe dry eye disease: the ESSENCE-2 randomized clinical trial. JAMA Ophthalmol. 2023;141(5):459-466.
3. Nordic Pharma launches LACRIFILL Canalicular Gel for dry eye therapy in the US [press release]. Nordic Pharma. May 29, 2024. Accessed January 5, 2025. www.nordicpharma.com/nordic-group-b-v-through-its-subsidiary-nordic-pharma-inc-u-s-announces-the-launch-of-lacrifill-canalicular-gel-a-novel-therapy-for-dry-eye/
4. Packer M, Lindstrom R, Thompson V, et al. Effectiveness and safety of a novel crosslinked hyaluronate canalicular gel occlusive device for dry eye. J Cataract Refract Surg. 2024;50(10):1051-1057.
5. Gioia N, Gerson J, Ryan R, et al. A novel multi-ingredient supplement significantly improves ocular symptom severity and tear production in patients with dry eye disease: results from a randomized, placebo-controlled clinical trial. Front Ophthalmol (Lausanne). 2024;4:1362113.
6. Formosa Pharmaceuticals announces successful top-line results from CPN-303, a phase 3 trial in Chinese subjects for the treatment of inflammation and pain after cataract surgery [press release]. November 4, 2024. Accessed January 5, 2025. www.formosapharma.com/formosa-pharmaceuticals-announces-successful-top-line-results-from-cpn-303-a-phase-3-trial-in-chinese-subjects-for-the-treatment-of-inflammation-and-pain-after-cataract-surgery/
7. Formosa Pharmaceuticals and AimMax Therapeutics receive FDA approval for clobetasol propionate ophthalmic suspension 0.05%, for the treatment of post-operative inflammation and pain following ocular surgery [press release]. Formosa Pharmaceuticals. March 4, 2024. Accessed January 5, 2025. www.prnewswire.com/news-releases/formosa-pharmaceuticals-and-aimmax-therapeutics-receive-fda-approval-for-clobetasol-propionate-ophthalmic-suspension-0-05-for-the-treatment-of-post-operative-inflammation-and-pain-following-ocular-surgery-302079089.html
8. FDA clears Novoxel’s Tixel for the treatment of Meibomian gland Dysfunction. Eyewire+. November 27, 2024. Accessed January 5, 2025. eyewire.news/news/fda-clears-novoxels-tixel-for-the-treatment-of-meibomian-gland-dysfunction
9. Bausch + Lomb receives FDA approval for Teneo Excimer Laser Platform for myopia and myopic astigmatism LASIK vision correction surgery. Businesswire. January 8, 2024. Accessed January 5, 2025. www.businesswire.com/news/home/20240108249683/en/Bausch-Lomb-Receives-FDA-Approval-for-TENEO%E2%84%A2-Excimer-Laser-Platform-for-Myopia-and-Myopic-Astigmatism-LASIK-Vision-Correction-Surgery
10. FDA approves VISUMAX 800 with SMILE Pro software for refractive surgery [press release]. Zeiss. January 11, 2024. Accessed January 5, 2025. www.zeiss.com/meditec-ag/en/media-news/press-releases/2024/fda-approves-visumax-800-with-smile-pro.html
11. RxSight, Inc. announces the commercial launch of its newest Light Adjustable Lens+ (LAL+) and features multiple doctor presentations at the upcoming ASCRS annual meeting [press release]. RxSight. April 4, 2024. Accessed January 5, 2025. investors.rxsight.com/news-releases/news-release-details/rxsight-announces-commercial-launch-its-newest-light-adjustable
12. Johnson & Johnson rolls out new TECNIS Odyssey next-generation intraocular lens offering cataract patients precise vision at every distance in any lighting [press release]. Johnson & Johnson. September 30, 2024. Accessed January 5, 2025. www.jnj.com/media-center/press-releases/johnson-johnson-rolls-out-new-tecnis-odyssey-next-generation-intraocular-lens-offering-cataract-patients-precise-vision-at-every-distance-in-any-lighting
13. Bausch + Lomb receives FDA approval for enVista Envy full range of vision intraocular lens. BusinessWire. October 14, 2024. Accessed January 5, 2025. www.businesswire.com/news/home/20241014506149/en/Bausch-Lomb-Receives-FDA-Approval-for-enVista%C2%AE-Envy%E2%84%A2-Full-Range-of-Vision-Intraocular-Lens
14. Sarkisian SR, Ang RE, Lee AM, et al. Travoprost Intracameral Implant for open-angle glaucoma or ocular hypertension: 12-month results of a randomized, double-masked trial. Ophthalmol Ther. 2024;13(4):995-1014.
15. Lupin receives approval from US FDA for Travoprost ophthalmic solution USP [press release]. Lupin. May 6, 2024. Accessed January 5, 2025. www.lupin.com/lupin-receives-approval-from-u-s-fda-for-travoprost-ophthalmic-solution-usp/#:~:text=Mumbai%2C%20Naples%2C%20May%2006%2C,Solution)%2C%20to%20market%20a%20generic
16. Glaukos announces FDA approval of iDose TR (travoprost intracameral implant) [press release]. Glaukos. December 14, 2023. Accessed January 5, 2025. investors.glaukos.com/investors/news/news-details/2023/Glaukos-Announces-FDA-Approval-of-iDoseTR-travoprost-intracameral-implant/default.aspx
17. FDA grants denovo classification to Balance Ophthalmics’ FYSX Ocular Pressure Adjusting Pump. Eyewire+. June 28, 2024. Accessed January 5, 2025. eyewire.news/news/fda-grants-denovo-classification-to-balance-ophthalmics-fysxtm-ocular-pressure-adjusting-pump
18. Medeiros FA, Walters TR, Kolko M, et al; ARTEMIS 1 Study Group. Phase 3, randomized, 20-month study of bimatoprost implant in open-angle glaucoma and ocular hypertension (ARTEMIS 1). Ophthalmology. 2020;127(12):1627-1641.
19. FDA ophthalmic devices panel meeting. FYSX Ocular Pressure Adjusting Pump: Summary of Safety and Effectiveness Data (SSED). US FDA. March 21, 2024. Accessed January 5, 2025. www.fda.gov/media/177274/download
20. Delaney-Gesing A. FDA clears Belkin Vision’s Eagle device for SLT. Eyes On Eyecare. December 12, 2023. Accessed January 5, 2025. glance.eyesoneyecare.com/stories/2023-12-12/fda-clears-belkin-vision-s-eagle-device-for-slt/
21. Alcon completes acquisition of Belkin Vision, expanding glaucoma portfolio with Direct Selective Laser Trabeculoplasty (DSLT) technology [press release]. Alcon. May 1, 2024. Accessed January 5, 2025. www.alcon.com/media-release/alcon-completes-acquisition-belkin-vision-expanding-glaucoma-portfolio-direct/
22. Congdon N, Azuara-Blanco A, Solberg Y, et al; GLAUrious study group. Direct selective laser trabeculoplasty in open angle glaucoma study design: a multicentre, randomised, controlled, investigator-masked trial (GLAUrious). Br J Ophthalmol. 2023;107(1):62-65.
23. FDA approves first interchangeable biosimilars to Eylea to treat macular degeneration and other eye conditions. US FDA. May 20, 2024. Accessed January 5, 2025. www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilars-eylea-treat-macular-degeneration-and-other-eye
24. Formycon receives FDA approval for FYB203/Ahzantive (aflibercept-mrbb), a biosimilar to Eylea [press release]. Formycon. July 1, 2024. Accessed January 5, 2025. www.formycon.com/en/blog/press-release/formycon-receives-fda-approval-for-fyb203-ahzantive/#:~:text=Planegg%2DMartinsried%2C%20Germany%20%E2%80%93%20Formycon,%2C%20on%20June%2028%2C%202024
25. Sandoz receives FDA approval for Enzeevu (aflibercept-abzv), further strengthening US biosimilar position [press release]. Sandoz. December 8, 2024. Accessed January 5, 2025. www.us.sandoz.com/sandoz-receives-fda-approval-enzeevutm-aflibercept-abzv-further-strengthening-us-biosimilar/
26. Jeremias S. FDA approves Pavblu for retinal conditions. AJMC. September 17, 2024. Accessed January 5, 2025. www.centerforbiosimilars.com/view/fda-approves-pavblu-for-retinal-conditions
27. LumiThera obtains FDA authorization of Valeda treatment for dry AMD patients to improve vision [press release]. LumiThera. November 4, 2024. Accessed January 5, 2025. www.lumithera.com/lumithera-obtains-fda-authorization-of-valeda-treatment-for-dry-amd-patients-to-improve-vision/
28. Viatris and Ocuphire Pharma announce FDA approval of Ryzumvi (phentolamine ophthalmic solution) 0.75% eye drops for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (eg, phenylephrine) or parasympatholytic (eg, tro) [press release]. Viatris and Ocuphire Pharma. September 27, 2023. Accessed January 5, 2025. investor.viatris.com/news-releases/news-release-details/viatris-and-ocuphire-pharma-announce-fda-approval-ryzumvltm
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